The Effect of Systemic Nonsteroidal Anti-inflammatory Drugs (NSAIDs) Vs Intraoperative Infiltration of Steroids in Tonsillar Bed Following Tonsillectomy on Post Tonsillectomy Pain.
NSAIDs
1 other identifier
interventional
75
1 country
1
Brief Summary
The aim of this study is to compare the efficacy of adding paracetamol to systemic non-steroidal anti-inflammatory drugs (NSAIDs) versus adding dexamethasone as local infiltration to paracetamol on post tonsillectomy pain control.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2025
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 8, 2025
CompletedFirst Submitted
Initial submission to the registry
April 4, 2025
CompletedFirst Posted
Study publicly available on registry
June 25, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2025
CompletedJune 25, 2025
May 1, 2025
4 months
April 4, 2025
June 15, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
post tonsillectomy pain
The primary endpoints that will be used is resting pain scores using virtual analogue scale; VAS score (0: no pain-10: worst pain) at DAY 0 after 6h, 24h and DAY 5 post-operatively. Where pain score will be measured at multiple points during the outcome intervals, the pain scores at the time closest to six and 24h will be used.
DAY 0 6h, 24h post-operatively and DAY 5 post-operatively
Secondary Outcomes (3)
Additional pain medication needed
2 weeks post operatively
Pt feedback after tonsillectomy
2 weeks post operatively
Complications
2 weeks post operatively
Study Arms (3)
1- First group: will receive local infiltration of steroids (dexamethasone) in tonsillar bed and par
EXPERIMENTAL1- First group: will receive local infiltration of steroids (dexamethasone) in tonsillar bed and par
2- Second group: will receive systemic nonsteroidal anti-inflammatory drugs in the analgesic and ant
EXPERIMENTAL2- Second group: will receive systemic nonsteroidal anti-inflammatory drugs in the analgesic and anti-inflammatory dosage and paracetamol.
3- Third group: control group will receive NSAIDs, steroids and paracetamol as standard post tonsill
ACTIVE COMPARATOR3- Third group: control group will receive NSAIDs, steroids and paracetamol as standard post tonsill
Interventions
1- First group: will receive local infiltration of steroids (dexamethasone) in tonsillar bed and paracetamol.
2- Second group: will receive systemic nonsteroidal anti-inflammatory drugs in the analgesic and anti-inflammatory dosage and paracetamol.
3- Third group: control group will receive NSAIDs, steroids and paracetamol as standard post tonsillectomy medications in our department.
Eligibility Criteria
You may qualify if:
- Age: Between 4-10 years.
- Indications of tonsillectomy such as:
- Recurrent acute attacks at least 7 episodes in the past year or at least 5 episodes per year for 2 years or at least 3 episodes per year for 3 years.
- Chronic tonsillitis and hypertrophy of tonsils causing sleep apnea, difficulty in deglutition, interference in speech.
- Tonsillectomy by cold dissection only.
- American Society of Anesthesiologists (ASA) classification 1,2 (Normal Health, Mild systematic disease).
You may not qualify if:
- Patients with age less than 4 and more than 10 years.
- Indications of tonsillectomy other than chronic tonsillitis such as lymphoma.
- Patients on chronic steroid therapy
- Hemoglobin level less than 10 gm/dL
- Presence of acute infection in the upper respiratory tract, acute tonsillitis
- American Society of Anesthesiologists (ASA) classification ASA 3,4 (Severe systematic disease such as uncontrolled Diabetes, cardiac disease, liver or kidney disease, life threating medical conditions)
- Regular use of analgesics within a week of surgery.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ainshams university hospitals
Cairo, Egypt
Related Publications (1)
Verma RR, Sriraman R, Rana SK, Ponnanna NM, Rajendar B, Ghantasala P, Rajendra L, Matur RV, Srinivasan VA. E6 protein of human papillomavirus 16 (HPV16) expressed in Escherichia coli sans a stretch of hydrophobic amino acids, enables purification of GST-DeltaE6 in the soluble form and retains the binding ability to p53. Protein Expr Purif. 2013 Nov;92(1):41-7. doi: 10.1016/j.pep.2013.08.010. Epub 2013 Sep 6.
PMID: 24012792BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 4, 2025
First Posted
June 25, 2025
Study Start
March 8, 2025
Primary Completion
July 1, 2025
Study Completion
August 1, 2025
Last Updated
June 25, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will not share